Clinical Study of Metronomic Oral Cyclophosphamide in Patients With Advanced Sarcomas

NCT01716689 | Completed Phase 2

• 1 other identifier: NCC1201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm phase II clinical study to evaluate the efficacy and safety of metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced sarcomas.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Clinical benefit as defined by the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting > 12 weeks per RECIST 1.1 as a measure of disease control

  24 months

Secondary Outcomes (3)

• Assessment of objective response rate (ORR)

  24 months

• Assessment of progression free survival

  24 months

• Assessment on duration of response to oral metronomic cyclophosphamide in patients who exhibit objective responses

  24 months

Study Arms (1)

Patients with advanced sarcoma

EXPERIMENTAL

Drug: oral cyclophosphamide

Interventions

oral cyclophosphamide DRUG

50mg daily

Patients with advanced sarcoma

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must have histologically or cytologically confirmed, metastatic and/or unresectable high grade sarcoma for which standard multi-modality curative therapies do not exist or are no longer effective. Patients with low grade sarcoma need to additionally demonstrate disease progression in the last 6 months prior to study entry.
• Age \> 21 years
• Prior anti-sarcoma chemotherapy
• Participants who are 21 to 64 years of age at the time of study entry must have received at least one line of established chemotherapy, if such treatment exists; or refused such treatment, which includes either an anthracycline and/or ifosfamide. Patients whose sarcomas do not have known established therapy are eligible for this study without the requirement of a prior therapy.
• Participants \> 65 years of age at the time of study entry are eligible for this study without the requirement for prior treatment
• ECOG performance status 0-3 (see Annex A)
• Measurable disease outside of a prior irradiated area as defined by RECIST 1.1 guidelines. A lesion in a previously irradiated area is not eligible for measurable disease unless there is objective evidence of progression of the lesion prior to study enrollment
• No limit to number of prior chemotherapies or biologics
• Participants must have normal organ function as defined below:
• Hemoglobin \> 10g/dL
• Absolute neutrophil count (ANC) \> 1500/mm3
• Platelet count \> 75,000/mm3
• Total bilirubin \< 1.5 times institutional upper limits or normal (ULN)
• AST/ALT \< 3 times ULN (\< 5 times ULN if hepatic involvement is present)

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Patients diagnosed with gastrointestinal stromal tumor (GIST)
• Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
• Palliative radiotherapy or major surgery within 3 weeks of study entry
• Concurrent use of any other anti-cancer therapies or study agents
• Symptomatic or uncontrolled brain or central nervous system metastases
• Participants may not be receiving any other concomitant investigational agents
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Richard Quek

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: October 30, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

SG (1)